D-1740-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 21, 2019
- Initiation Date
- July 11, 2019
- Termination Date
- June 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 147 cases
Product Description
Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.
Reason for Recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot # a) 21J18, EXP 07/2021 b) 42H18, EXP 06/2021; c) 32H18, EXP 6/2021